Drug delivery system with a delay mechanism

ABSTRACT

A medicament delivery system, including a medicament container and a delay mechanism that is activated prior to completion of medicament delivery from the medicament container. The delay mechanism automatically activates a subsystem or initiates an operation subsequent to completion of medicament delivery.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a division of U.S. Pat. No. 10,220,151, issued onMar. 5, 2019, which is the U.S. national stage of International PatentApplication No. PCT/US2012/066057, filed on Nov. 20, 2012, which claimspriority under 35 USC § 119(e) from U.S. Provisional Patent ApplicationSer. No. 61/562,500, filed on Nov. 22, 2011, the disclosures of whichare incorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates to drug or medicament delivery systems,and more particularly, to a drug or medicament delivery system with adelay mechanism.

2. Description of the Related Art

Medicament delivery systems can have multiple subsystem interactions,for example, device activation, valve operation to connect a medicamentcontainer with a patient needle, commencement of medicament delivery,needle protrusion, needle withdrawal, and end-of-dose indication. Insuch medicament delivery systems, each subsystem has a dimensionaltolerance. Thus, in the entire device, the accretion of tolerancescreates a tolerance window for when the complete dose has beendelivered. It is undesirable, for example, to indicate an end-of-dose orwithdraw a patient needle prior to the actual dose completion.Accordingly, it would beneficial to have a delay mechanism to ensuredose completion prior to activating such subsystems or operations.

SUMMARY OF EMBODIMENTS OF THE INVENTION

Accordingly, it is an aspect of the present invention to provide amedicament delivery system with a delay mechanism to ensure dosecompletion prior to activation of at least one subsystem or operation.

The foregoing and/or other aspects of the present invention are achievedby providing a medicament delivery system, including a medicamentcontainer and a delay mechanism that is activated prior to completion ofmedicament delivery from the medicament container. The delay mechanismautomatically activates a subsystem or initiates an operation subsequentto completion of medicament delivery.

The foregoing and/or other aspects of the present invention are alsoachieved by providing a method of delivering a medicament, the methodincluding receiving an activation command, and in response to receivingthe activation command, releasing an ejection mechanism to ejectmedicament from a container. The method also includes, prior to ejectingsubstantially all the medicament from the container, activating a delaymechanism, and subsequent to ejecting substantially all of themedicament from the container, automatically activating a subsystem orinitiating an operation via the delay mechanism.

Additional and/or other aspects and advantages of embodiments of thepresent invention will be set forth in the description that follows, orwill be apparent from the description, or may be learned by practice ofthe invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and/or other aspects and advantages of embodiments of theinvention will become apparent and more readily appreciated from thefollowing detailed description, taken in conjunction with theaccompanying drawings, in which:

FIG. 1 is a top perspective view of a medicament delivery device inaccordance with an embodiment of the present invention;

FIGS. 2 and 3 are perspective views of the interior of the device ofFIG. 1 illustrating the operation thereof;

FIG. 4 is a partial perspective view of a column base of the device ofFIG. 1;

FIG. 5 is a perspective bottom view of a column member of the device ofFIG. 1 Fig.;

FIGS. 6-9 are perspective views of the interior of the device of FIG. 1illustrating the operation thereof;

FIGS. 10 and 11 are partial perspective views of the device of FIG. 1illustrating an alternative pallet member;

FIGS. 12 and 13 are a partial perspective views of a medicament deliverydevice in accordance with another embodiment of the present invention;

FIGS. 14 and 15 are side perspective view of the device of FIG. 12illustrating the activation of a delay mechanism;

FIGS. 16-18 are partial perspective views of a medicament deliverydevice in accordance with another embodiment of the present invention;

FIGS. 19 and 20 are partial perspective views of a medicament deliverydevice in accordance with another embodiment of the present invention;

FIG. 21 illustrates a delay mechanism in accordance with anotherembodiment of the present invention;

FIG. 22 is a partial perspective view of a medicament delivery device inaccordance with another embodiment of the present invention;

FIGS. 23 and 24 illustrate alternative column assemblies in accordancewith further embodiments of the present invention;

FIGS. 25-28 illustrate a column assembly in accordance with anotherembodiment of the present invention; and

FIG. 29 illustrates an activation mechanism in accordance with anotherembodiment of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE PRESENT INVENTION

Reference will now be made in detail to embodiments of the presentinvention, which are illustrated in the accompanying drawings, whereinlike reference numerals refer to like elements throughout. Theembodiments described herein exemplify, but do not limit, the presentinvention by referring to the drawings. As will be understood by oneskilled in the art, terms such as up, down, bottom, and top arerelative, and are employed to aid illustration, but are not limiting.

FIG. 1 is a top perspective view of a medicament delivery device 100 inaccordance with an embodiment of the present invention. The device 100includes a main body 102, an activation button 104, and a safety 106. Tooperate the device 100, the user first slides the safety 106 away fromthe activation button 104 to disengage the safety 106 from theactivation button 104. At this stage, subsequent to placing the device100 on the patient's skin, the user can depress the activation button104 to begin the process of medicament delivery. It will be understoodby those skilled in the art that the user and the patient may bedifferent people, or that the user and the patient may be the sameperson. The terms “user” and “patient” will sometimes be usedinterchangeably hereinafter. It will be understood that embodiments ofthe invention are not limited to those in which the user and the patientare the same person or to those in which the user and the patient aredifferent people.

FIGS. 2, 3, and 6-9 are perspective views of the interior of the device100 illustrating the operation thereof. The device 100 includes a base108, a liquid medicament container 110 with a stopper 112 movablydisposed therein, and, as will be subsequently described in greaterdetail, a delay mechanism that is automatically activated prior tocompletion of medicament delivery. The delay mechanism automaticallyactivates a subsystem or initiates an operation subsequent to completionof medicament delivery.

The device 100 also includes a valve 114, a sliding bracket 116, abiased plunger 118 for displacing the stopper 112 within the medicamentcontainer 110 to dispense the medicament, and a shutter 120 forselectively retaining and releasing the plunger 118. According to oneembodiment, the device 100 additionally has an injection/retractioncolumn assembly 122, which includes the activation button 104.

As shown, in FIG. 3, in which the activation button 104 is illustratedas being transparent, the column assembly 122 also includes a needlearbor 124 in which a patient needle 126 (shown, e.g., in FIGS. 14 and15) is disposed, a column base 128, a needle spring 130 biasing theneedle arbor downward, and a column member 132. According to oneembodiment, the column base 128 is integrally formed as a unitarystructure with the base 108. According to another embodiment, the columnbase 128 is attached to the base 108. As shown in FIG. 4, the columnbase 128 includes a guide surface 134 for guiding rotation of the needlearbor 124, and a guide portion 136 for guiding vertical displacement ofthe needle arbor 124 to extend the needle 126 beyond the base 108 forinsertion into the user. In addition, multiple retaining portions 138are disposed about the column base 128.

As subsequently discussed in greater detail, the retaining portions 138interact with feet 140 of the column member 132, which is shown in FIG.5. The column member 132 also includes a gear portion 142 forinterfacing with the delay mechanism.

In operation of the device 100, after displacing the safety 106, theaction of depressing the activation button 104 (the state illustrated inFIG. 3) releases the biased sliding bracket 116. The sliding motion ofthe sliding bracket 116 rotates the needle arbor 124 until the arms ofthe needle arbor 124 reach the guiding portion 136 (FIG. 6), at whichpoint the needle spring 130 displaces the needle arbor 124 downwardalong the guiding portion 136 to displace the needle 126 outside of thedevice 100 and into the user (FIG. 7). The sliding motion of the slidingbracket 116 also opens the valve 114 (FIG. 8) and activates the shutter120 (FIGS. 6-8), which releases the biased plunger 118 to begindisplacing the stopper 112 within the medicament container 110.

As noted previously, the collective tolerances of the various componentsof a medicament delivery device may affect the time required to delivera complete dose. For example, the length of the stopper, the innerdiameter of the medicament container, the inner diameter of the needle,and the inner diameter of the connection between the medicamentcontainer and the needle, may all affect the flow rate of themedicament, and thus the amount of time required to complete delivery ofthe dose.

Because of the expense of some medicaments, users want delivery ofsubstantially 100% of the dosage, and may want an indication of when thedose has been delivered. But because of the collective tolerances of thevarious components, the certainty of dose completion may be difficult todetermine, particularly if the dose is administered over a relativelylong period of time, such as 5, 10, 20, or 60 minutes. For example, ifthe collective tolerances of the various components yields 10%variability in the rate of dosage delivery, with a target dosagedelivery time of 60 minutes, the dose could be delivered in 54 minutesor 66 minutes. Accordingly, it is desirable to have a delay mechanism toactivate one or more post-delivery subsystems or operations, such asvalve closure, end-of-dose indication, or needle protection. Such adelay mechanism can be triggered, for example, at 90 or 95% of dosecompletion, and then, after the predetermined delay, which would ensuredose completion, the delay mechanism can activate the subsystem orinitiate the operation.

According to one embodiment, the plunger 118 includes a tail portion 144that is wrapped around a spool 146, which includes a spool arm 148. Asthe plunger 118 displaces the stopper 112 within the medicamentcontainer 110, the tail portion 144 unwinds from the spool 146, therebyrotating the spool 146 and the spool arm 148. After a predetermineddisplacement of the plunger 118 and stopper 112, and a correspondingamount of rotation of the spool 146, the spool arm 148 engages a delayactuator 150, which activates the delay mechanism. According to oneembodiment, the spool arm 148 engages a cam surface 152 (best shown inFIG. 11) of the delay actuator 150 to rotate the delay actuator 150 outof engagement with a pallet member.

As shown in FIGS. 2, 3, and 6-9, a delay mechanism 154 includes abiasing mechanism. According to one embodiment, the biasing mechanismincludes a spring 174 wound between two spools 176 and 178 (see, e.g.FIG. 6). Spool 176 is concentrically disposed with a shaft 158 to rotatetherewith. The delay mechanism 154 also includes a pallet member 156 anda shaft 158. The pallet member 156 includes a base portion 160 and apair of opposing pallet arms 162 extending from the base portion 160.The base portion 160 is rotatably connected to the base 108. Accordingto one embodiment, the base portion 160 is biased to a neutral position.To accomplish this neutral bias, the pallet member 156 includes abiasing portion 164 (see, e.g. FIG. 2).

The shaft 158 includes a worm gear 166 that engages the gear portion 142of the column member 132. The shaft 158 also includes an impulse wheelor disc 168 having teeth or cogs 170 circumferentially disposed onopposing sides thereof for interacting with the pallet arms 162.

Once the spool arm 148 engages the cam surface 152 of the delay actuator150 to rotate the delay actuator 150 out of engagement with the palletmember 156, thereby activating the delay mechanism 154, the palletmember 156 is free to oscillate about its rotational axis. Because ofthe bias of spring 174, the shaft 158 rotates, thereby causing teeth 170on opposing sides of the wheel 168 to alternately engage the pallet arms162. This interaction delays rotation of the shaft 158.

The rotation of the shaft 158 also rotates the worm gear 166, which,because of its interaction with the gear portion 142, causes therotation of the injection/retraction column assembly 122, as shown inFIG. 8. Subsequent to a predetermined amount of rotation of the columnassembly 122, which occurs subsequent to the completion of medicamentdelivery, feet 140 of the column member 132 no longer align with theretaining portions 138 of the column base 128, and a column spring 180displaces the column assembly 122 upward, away from the user (FIG. 9).This column assembly displacement withdraws the needle from the user'sskin and back within the device 100. Thus, according to one embodiment,the delay mechanism 154 automatically activates a subsystem (the needlesafety mechanism) subsequent to completion of medicament delivery.Additionally, because of the location of the activation button 104 onthe column assembly 122, when the column assembly 122 moves upward, theactivation button 104 also moves upward, thereby serving as a visualend-of-dose indicator. Further, according to one embodiment, the upwardmovement of the column assembly 122 serves as an audible and tactilefeedback indicating dosage completion.

Several factors can be designed to affect the total delay of the delaymechanism 154. For example, the length of the tail 144, the diameter ofthe spool 146, and the initial angular position of the spool arm 148.Additional factors include the number, size, and shape of the teeth 170,the diameter of the disc 168, how quickly the pallet member 156oscillates (i.e. length of pallet arms 162 and/or strength of biasingelement 164), and how powerful the spring 174 is.

FIGS. 10 and 11 are partial perspective views of the device of FIG. 1illustrating an alternative pallet member. In this embodiment, ratherthan the biasing portion 164, the pallet member 182 includes one or moresprings inside a central column 184. This internal spring biases thepallet member to the neutral position.

FIG. 12 is a partial perspective view of a medicament delivery device200 in accordance with another embodiment of the present invention. Inmany respects, the device 200 functions substantially similarly to thepreviously-described device 100. Accordingly, for brevity, redundantdescription is omitted. The device 200 employs a delay mechanism 202that includes a plurality of intermeshing gears 204 and a rocking arm206 having a plurality of paddles or blades thereon. In this embodiment,the delay actuator 208 includes a pivoting arm 208 having a cam surface210 at a first end thereof for interacting with the spool arm 152. Asecond, opposing end of the pivoting arm 208 initially engages a coggear 212 (FIGS. 12-14) to prevent rotation of the gears 204.

The gears 204 also include an interface gear 214 that interfaces withthe gear portion 142 to selectively rotate the column assembly 122.Additionally, as shown in FIG. 13, the gears 204 are biased by a biasingmember 216, such as a clock spring 216. One skilled in the art willappreciate that other biasing members can be employed without departingfrom the scope of the present invention.

The cog gear 212 has a plurality of cogs 218 that interact with both thepivoting arm 208 and the rocking arm 206. In operation, prior tocompletion of the medicament dose, once the spool arm 152 rotates overthe cam surface 210 to pivot the pivoting arm 208 out of contact withthe cog 218 of the cog gear 212 (FIG. 15), the cog gear 212 (and theremaining intermeshed gears) begins to rotate under the influence of thebiasing member 216. As the cog gear rotates, successive cogs 218slidingly engage alternating ones of the paddles 220 of the rocking arm206.

This interaction of the escapement mechanism delays the rotation of thegears 204, so that, subsequent to the completion of the medicamentdosage, the column assembly 122 rotates until the feet 140 of the columnmember 132 no longer align with the retaining portions 138 of the columnbase 128, and the column spring 180 displaces the column assembly 122upward. Thus, the delay mechanism 202 automatically activates asubsystem (the needle safety mechanism and/or the end-of-dose indicator)subsequent to completion of medicament delivery.

FIGS. 16-18 are partial perspective views of a medicament deliverydevice 230 in accordance with another embodiment of the presentinvention. In many respects, the device 230 functions substantiallysimilarly to the previously-described device 100. Accordingly, forbrevity, redundant description is omitted. In addition to the columnspring 180 biasing the column assembly 122 upward, the column assembly122 includes a column torsion spring 232 rotatably biasing the columnassembly 122.

In this embodiment, the delay activator 234 includes a rotating armportion 236 and an engaging portion 238. The engaging portion 238 has afirst end for selective engagement with the spool arm 152 and a second,opposing end for selective engagement with a notch 239 in the columnassembly 122. As shown in FIG. 16, the engaging portion engages thenotch 239 to selectively prevent rotation of the column assembly 122.

The device 230 also includes a delay mechanism including a dampenercartridge 240 with a gear 242 thereon for engagement with the gearportion 142. According to one embodiment, the dampener cartridge 240includes a viscous fluid, such as silicone, that is pushed throughopenings when the gear 242 rotates. One skilled in the art willappreciate that other viscous fluids or non-Newtonian fluids can beemployed without departing from the scope of the present invention.

Prior to completion of the medicament dosage, the spool arm 152 contactsthe engaging portion 238 and the rotating arm portion 236 rotates theengaging portion 238 out of engagement with the notch 239, therebyfreeing the column assembly 122 to rotate under the influence of thecolumn torsion spring 232. The engagement between the gear portion 142and the gear 242 of the dampener cartridge 240, however, delays thecompletion of the rotation of the column assembly 122 until after thecompletion of the medicament delivery (FIG. 17). At the completion ofthe rotation of the column assembly (FIG. 18), the column spring 180drives the column assembly upward.

According to one embodiment, if the energy of column torsion spring 232is not spent at the completion of the column assembly 122 rotation, thespring 232 expends its remaining energy freely subsequent to the upwardmovement of the column assembly 122.

FIGS. 19 and 20 are partial perspective views of a medicament deliverydevice 250 in accordance with another embodiment of the presentinvention. In many respects, the device 250 functions substantiallysimilarly to the previously-described device 100. Accordingly, forbrevity, redundant description is omitted. In addition to the columnspring 180 biasing the column assembly 122 upward, the column assembly122 includes a column torsion spring (similar to column torsion spring232, although not shown in FIGS. 19 and 20) rotatably biasing the columnassembly 122. Further, the column assembly 122 in the device 250 lacks agear portion 142 disposed thereon.

The device 250 has a delay mechanism 252 that includes a solenoid 254and an arm 256 connected to the solenoid 254 and rotatably connected tothe base 108. The delay mechanism 252 also includes a controller 258,such as a printed circuit board (PCB), and a portable power source 260.Although depicted as a pair of size AAA batteries, one skilled in theart will appreciate that other portable power sources, such as watch orbutton batteries, can be employed without departing from the scope ofthe present invention.

In operation, prior to completion of the medicament dosage, the delaymechanism is activated. Once activated, the controller 258 starts adelay timer. At the expiration of the delay timer, the controller 258controls the solenoid 254 to disengage the arm 256 from a notch 262 inthe column assembly 122, thereby freeing the column assembly 122 torotate under the influence of the column torsion spring. According toone embodiment, the delay timer does not release the arm from the notch262 until after the completion of the medicament dosage (FIG. 20), andthe rotation of the column assembly 122 is substantially unimpeded.

Additionally, in the depicted embodiment of the device 250, the spool146 is connected with the controller 258 to input to the controller 258when the plunger 118 has displaced by a predetermined amount. Oneskilled in the art will appreciate, however, that other devices may beused to create this input without departing from the scope of thepresent invention. For example, an optical sensor can be employed suchthat when the stopper 112 breaks a light beam, the controller 258 startsthe delay timer. As another example, a pressure sensor may be employedwithin the medicament container 110. As a further example, magnets or anRFID chip may be employed on the plunger to detect when the plunger 118passes a predetermined position, to then signal the controller 258 tostart the delay timer. One skilled in the art will also appreciate thatthe actual delay of the delay timer can vary based on the particularsensor or input selected for the device 250.

FIG. 21 illustrates another embodiment of a delay mechanism. In thisembodiment, once the plunger passes a predetermined displacement, afollower 302 is released and is constrained to follow an elongated path304. That is, the elongated path 304 is longer than the path followed bythe plunger. Therefore, the arrival of the follower 302 at the end ofthe elongated path 304 triggers a subsystem and provides a delayrelative to the completion of the plunger stroke.

FIG. 22 is a partial perspective view of a medicament delivery device270 in accordance with another embodiment of the present invention. Inthis embodiment, the plunger 272 is spring-loaded. Additionally, ratherthan being connected with the column assembly 274, the activation button(not shown) is connected with a spring-loaded keyhole plate 276. Whenthe activation button is depressed by the user, the keyhole plate 276moves downward until the plunger is permitted to pass therethrough.

According to one embodiment, the needle protection and the end-of-doseindicator are separate. For example, the user may activate a needleprotection mechanism after an end-of-dose indicator becomes visible.

FIGS. 23 and 24 illustrate an alternative embodiment of a columnassembly 280. As shown in FIG. 23, when the user depresses theactivation button 282, latching fingers 284 are forced radially outwardby angled supports 286, thereby permitting an inner spring 288 to drivethe needle 290 into the user. Subsequently, as shown in FIG. 24,rotation of the column assembly 280 forces retaining fingers 292radially outward because of contact with ramped surfaces 294. Thisaction permits the outer spring 296 (see FIG. 23) to drive the columnassembly 280 upward.

FIGS. 25-28 illustrate a column assembly 320 in accordance with anotherembodiment of the present invention. The column assembly 320 includes acolumn support structure 322 having a plurality of radially outwardprotruding ribs, and a needle motion column 324 disposed within thecolumn support structure 322 and biased upward by an outer spring 326that is supported on the protruding ribs. The column assembly 320 alsoincludes a needle hub 328 disposed within the needle motion column 324and biased downward by an inner spring 330. A retention clip 332selectively prevents downward displacement of the needle hub 328. Thecolumn assembly 320 further includes needle column retention tabs 334(see FIG. 28).

As the device is activated, the retention clip 332 is removed,permitting the inner spring 330 to drive the needle hub 328 (and thus,the needle) downward into the user's skin. To retract the needle, theneedle column retention tabs 334 are removed, thereby permitting theouter spring 326 to drive the needle motion column 324 upward, whichalso lifts the needle hub 328 upward. As an alternative, the function orplacement of the inner and outer springs 330 and 326 can be reversed.

FIG. 29 illustrates an activation mechanism 350 in accordance with anembodiment of the present invention. The activation mechanism 350includes a lockout member 352, a rotationally biased rotary actuator 356connected with a plunger 358, and a bulkhead 360. The lockout member 352is rotatably connected with a base. According to one embodiment, thelockout member 352 rotates on a pin relative to the base. According toanother embodiment, the lockout member 352 is cantilevered from the baseand flexes or deforms to rotate relative to the base. The lockout member352 includes a lockout pin 362 disposed at one end thereof andprotruding through the base. The lockout member 352 also includes alockout tab 364 at another end thereof. The lockout tab 364 selectivelyfits in a notch 366 in the rotary actuator 356.

In operation, when the device is placed on the user's skin, the skinforces the lockout tab 362 upward, thereby rotating the lockout member352. This rotation moves the lockout tab 364 out of engagement with thenotch 366 of the rotary actuator 356. The rotation of the rotaryactuator 356 rotates the plunger until a shaped portion of the plungeraligns with a corresponding shaped through hole in the bulkhead, atwhich time the plunger begins displacing relative to the medicamentcontainer under the influence of a pressurization spring.

Embodiments of the invention include a delay mechanism for triggeringsubsystems and/or operations, such as an end-of-dose indication, needleprotection, or valve closure. The delay mechanism is activated prior tothe completion of medicament delivery. After the medicament delivery hasbeen completed, the delay triggers the next subsystem or operation. Thedelay mechanism can be mechanical, electrical, electronic, and/orchemical in nature.

In a medicament delivery system or device that has multipleinteractions, there are dimensional tolerances that create a tolerancewindow for when the complete medicament dose has been delivered. Thereare circumstances where it is beneficial to have a delay after themedicament delivery. To make the end-of-dose indication accurate andtransparent to the user of the device, it should to be triggeredautomatically. Because there is a tolerance window, however, the delayfor the end-of-dose indicator needs to be triggered prior to the dosecompletion, so that the delay will guarantee that the full dose will bedelivered, and subsequently, the delay mechanism will trigger theend-of-dose indicator.

Additionally, needle protection can be initiated after a delay thatprovides enough time to give a high confidence that the medicamentdelivery has been completed. The user does not want the needleprotection to activate prior to complete dose delivery. This could leadto the medicament leaking onto the skin. Additionally, the patient mightnot know if the complete dose was delivered. Also, if a needleprotection device is pushed against the skin while still delivering thedose, it could push a short needle out of the skin inadvertently.Passive needle protection is ideal because the user does not have toperform any additional actions. In a home setting, if a patient takesthe medicament delivery system off the skin and a needle is stillprotruding, then a delayed passive needle protection would still coverthe needle without user input. Another advantage to a delay for needleprotection is that the needle can be retracted back into the deviceafter medicament delivery is complete.

There are situations where a drug delivery system can have one subsystemor coupled subsystems that are linked to the delay mechanism. Forexample, the end of dose indication subsystem can be coupled to theneedle protection subsystem. The delay can trigger the end of doseindication and the needle protection subsystem.

Further, there can be independent subsystems, such as an end of doseindication (perhaps electronic) that is not triggered by the delaymechanism. In such an embodiment, the delay triggers the needleprotection at some point after the end of dose indication has activated.The device may have already been removed from the body when the needleprotection activates.

By implementing a delay mechanism that is activated prior to thecompletion of the dose, the delay mechanism can be timed such that thedownstream subsystem (for example, end of dose indication, and/or valveclosure, and/or needle protection) is only activated after thecompletion of the dose delivery. For example, a first trigger that isactivated by the drug delivery can activate the time delay. A secondtrigger can be the end of the time delay and can activate the downstreamsubsystem.

While the embodiments shown and described are related to medicamentdelivery devices that deliver medicaments over an extended period oftime, one skilled in the art will understand that embodiments of thepresent invention can also be incorporated into pen injectors,autoinjectors, or the like. Also, while only certain mechanical andelectromechanical delay mechanisms are described, it will be understoodthat any type of mechanical, electromechanical, electrical, electronic,and/or chemical delay mechanism may be used in the practice of thepresent invention.

Although only a few embodiments of the present invention have been shownand described, the present invention is not limited to the describedembodiments. Instead, it will be appreciated by those skilled in the artthat changes may be made to these embodiments without departing from theprinciples and spirit of the invention, the scope of which is defined bythe appended claims and their equivalents.

What is claimed is:
 1. A method of delivering a medicament, the methodcomprising: receiving an activation command from depression of anactivation button; in response to receiving the activation command,releasing a biased sliding bracket that travels and releases an ejectionmechanism to eject the medicament from a container; subsequent toejecting a portion of the medicament from the container and prior toejecting substantially all of the medicament from the container,activating a delay mechanism; subsequent to ejecting substantially allof the medicament from the container and a predetermined time delayafter activation of the delay mechanism, automatically activating anend-of-dose indicator and automatically activating a needle safetymechanism; wherein the sliding bracket also opens a valve.
 2. The methodaccording to claim 1, wherein the ejection mechanism comprises a biasedplunger.
 3. The method according to claim 1, wherein the sliding bracketalso triggers insertion of a patient needle.
 4. A method of delivering amedicament, the method comprising: receiving an activation command fromdepression of an activation button; in response to receiving theactivation command, releasing a biased sliding bracket to travel apredetermined distance and subsequently release an ejection mechanism toeject the medicament from a container; subsequent to ejecting a portionof the medicament from the container and prior to ejecting substantiallyall of the medicament from the container, activating a delay mechanism;subsequent to ejecting substantially all of the medicament from thecontainer and a predetermined time delay after activation of the delaymechanism, automatically initiating an end-of-dose indication and needleshielding.
 5. A method of delivering a medicament, the methodcomprising: receiving an activation command; in response to receivingthe activation command, releasing an ejection mechanism to eject themedicament from a container; subsequent to ejecting a portion of themedicament from the container and prior to ejecting substantially all ofthe medicament from the container, activating a delay mechanism;subsequent to ejecting substantially all of the medicament from thecontainer and a predetermined time delay after activation of the delaymechanism, automatically initiating needle shielding, and closure of avalve disposed between the container and a patient needle.
 6. A methodof delivering a medicament, the method comprising: receiving anactivation command from depression of an activation button; in responseto receiving the activation command, releasing a plunger to travel in afirst direction to eject the medicament from a container; subsequent toejecting a portion of the medicament from the container and prior toejecting substantially all of the medicament from the container,activating a delay mechanism; subsequent to ejecting substantially allof the medicament from the container and a predetermined time delayafter activation of the delay mechanism, automatically activating anend-of-dose indicator and automatically activating a needle safetymechanism to withdraw a needle in a second direction not parallel to thefirst direction.
 7. A method of delivering a medicament, the methodcomprising: receiving an activation command from depression of anactivation button; in response to receiving the activation command,triggering insertion of a patient needle in a first direction andreleasing a plunger to travel in a second direction not parallel to thefirst direction to eject the medicament from a container; subsequent toejecting a portion of the medicament from the container and prior toejecting substantially all of the medicament from the container,activating a delay mechanism; subsequent to ejecting substantially allof the medicament from the container and a predetermined time delayafter activation of the delay mechanism, automatically activating anend-of-dose indicator and automatically activating a needle safetymechanism.
 8. A method of delivering a medicament, the methodcomprising: receiving an activation command from depression of anactivation button; in response to receiving the activation command,releasing a sliding bracket biased by a first biasing member to traveland release an ejection mechanism biased by a second biasing member toeject the medicament from a container; subsequent to ejecting a portionof the medicament from the container and prior to ejecting substantiallyall of the medicament from the container, activating a delay mechanism;subsequent to ejecting substantially all of the medicament from thecontainer and a predetermined time delay after activation of the delaymechanism, automatically activating an end-of-dose indicator andautomatically activating a needle safety mechanism.
 9. A method ofdelivering a medicament, the method comprising: receiving an activationcommand from depression of an activation button; in response toreceiving the activation command, releasing a sliding bracket biased bya first biasing member to travel and release a needle biased by a secondbiasing member to displace the needle; subsequent to ejecting a portionof the medicament from a container and prior to ejecting substantiallyall of the medicament from the container, activating a delay mechanism;subsequent to ejecting substantially all of the medicament from thecontainer and a predetermined time delay after activation of the delaymechanism, automatically activating an end-of-dose indicator andautomatically activating a needle safety mechanism.